1. Area of Invention
This invention relates to the treatment of multiple sclerosis (xe2x80x9cMSxe2x80x9d) and other demyelinating conditions.
2. History
MS is a chronic, often disabling disease of the central nervous system. Various and converging lines of evidence point to the possibility that the disease is caused by a disturbance in the immune function, although the cause of this disturbance has not been established. This disturbance permits cells of the immune system to xe2x80x9cattackxe2x80x9d myelin, the fat containing insulating sheath that surrounds the nerve axons located in the central nervous system (xe2x80x9cCNSxe2x80x9d). When myelin is damaged, electrical pulses cannot travel quickly or normally along nerve fiber pathways in the brain and spinal cord. This results in disruption of normal electrical conductivity within the axons, fatigue and disturbances of vision, strength, coordination, balance, sensation, and bladder and bowel function.
As such, MS is now a common and well-known neurological disorder that is characterized by episodic patches of inflammation and demyelination which can occur anywhere in the CNS. However, almost always without any involvement of the peripheral nerves associated therewith. Demyelination produces a situation analogous to that resulting from cracks or tears in an insulator surrounding an electrical cord. That is, when the insulating sheath is disrupted, the circuit is xe2x80x9cshort circuitedxe2x80x9d and the electrical apparatus associated therewith will function intermittently or nor at all. Such loss of myelin surrounding nerve fibers results in short circuits in nerves traversing the brain and the spinal cord that thereby result in symptoms of MS.
It is further found that such demyelination occurs in patches, as opposed to along the entire CNS. In addition, such demyelination may be intermittent. Therefore, such occurrences are disseminated in both time and space.
It is believed that the pathogenesis involves a local disruption of the blood brain barrier which causes a localized immune and inflammatory response, with consequent damage to myelin and hence to neurons.
Clinically, MS exists in both sexes and can occur at any age. However, its most common presentation is in the relatively young adult, often with a single focal lesion such as a damage of the optic nerve, an area of anesthesia (loss of sensation), or paraesthesia (localize loss of feeling), or muscular weakness. In addition, vertigo, double vision, localized pain, incontinence, and pain in the arms and legs may occur upon flexation of the neck, as well as a large variety of less common symptoms.
An initial attack of MS is often transient, and it may be weeks, months, or years before a further attack occurs. Some individuals may enjoy a stable, relatively event free condition for a great number of years, while other less fortunate ones may experience a continual downhill course ending in complete paralysis. There is, most commonly, a series of remission and relapses, in which each relapse leaves a patient somewhat worse than before. Relapses may be triggered by stressful events, viral infections or toxins. Therein, elevated body temperature, i.e., a fever, will make the condition worse, or as a reduction of temperature by, for example, a cold bath, may make the condition better.
It is the belief of the present inventor that an additional trigger in either the local disruption of the blood brain barrier, or the local response thereto is both environmentally related and related to certain serious nutritional deficiencies which, as are set forth below, particularly deplete the fatty tissue which comprises the myelin sheath, thereby increasing one susceptibility to the underlying condition. At present, there is no satisfactory treatment for MS. That is, steroids may produce a temporary improvement, however any beneficial effect invariably wears off. Clinical trials during the mid-1990s indicated that the use of interferon cannot reduce the risk of relapse. However, the effects thereof have been shown to be modest and most patients will still eventually deteriorate.
Previous researchers, most notably Chadwick (see Chadwick et al, xe2x80x9c5, Hydroxytryptophanxe2x80x94Induced Myclonus in Guinea Pigsxe2x80x9d Journal of Neurological Sciences, PP 157-165 (1976); Reynolds (see xe2x80x9cMS and Vitamin B12 metabolism,xe2x80x9d Journal of Neuroimmunolgy, pp 225-230, (1992); and Loder (see U.S. Pat. No. 6,096,737 (2000), entitled xe2x80x9cTreatment of MS and other Demyelinating Conditions using Lofepramine and in combination with L-phenylalanine, Tyrosine or Tryptophanand and possibly a Vitamin B12 Compound), all offer suggestions relative to treatment of MS.
The present invention however enjoys a primary focus of prevention of MS by those individuals believed to be, either by reason of genetics, mental state, conditions, environment, conditions of stress, or combinations thereof, to be uniquely susceptible to MS, or recurrences thereof. The present invention is also useful as a means of self-treatment by members of the public, in accordance with the specifics set forth below. This means employs a combination of non-prescription food and vitamin supplements available at most health food stores, and health and vitamin websites. Accordingly, the present invention, unlike the prior art, as represented above, does not require the use of prescription medication such as an anti-depressant, serotonin uptake inhibitor, or monoamine oxidase inhibitor with neurotransmitter inducing properties. Thus, the invention does not require the use of neuroactive prescription medication taken under the care of a physician but, rather, comprises a regimen of non-prescription food and vitamin supplements which are available to any member of the public.
This is of particular value to persons knowing or believing that, by reason of genetics, environment, stress, or empirical evidence comprising a MS marker, one is at risk for MS. While the prior art suggests the use of some of the components of the present novel method of prevention and treatment of MS such as L-phenylalanine (xe2x80x9cLPAxe2x80x9d), L-tryptophan, and vitamin B12, these supplements represent but a small number of components of the aggregate of the present inventive regimen.
Otherwise, the state-of-the-art in MS research, as it is relevant to the instant invention, simply suggests the usage of the likes of LPA, L-tryptophan, and vitamin B12, as a means of supplementing the action of a powerful nueroactive, anti-depressant prescription medications.
As is apparent, many prospective or actual victims of MS do not respond well to use of an anti-depressant and, in fact, the same may adversely impact their ability to function in life, particularly if the basis of the trigger of the MS auto-immune response does not have its basis in a psychiatrically recognized form of depression. Further, as is generally known, many individuals are allergic to anti-depressants such as Lofepramine. If the MS patient is such an individual, the use of an anti-depressant may actually exacerbate the MS condition.
The regimen of the instant invention include two phases, the first of which may be in the range of 45 days to 6 months. The second of which is in the range of 1 to 7 weeks. The regimen of Phase 1 includes a combination, as is more particularly set forth below, of L-phenylalanine (xe2x80x9cLPAxe2x80x9d), tyrosine, and a preferred form of tryptophan (described below). The regimen also includes lecithin, choline and primrose oil. The regimen further includes vitamins in the B family, namely, vitamin B12, niacin and folic acid. Additionally included in the regime are beta carortine, calcium and magnisium (all as are more fully described below).
In Phase 2, there is used lecithin, primrose oil and choline, as well as B12, niacin, folic acid, beta-carotene, vitamin C, calcium and magnisium.
For the above regimen, vital nutrients necessary to re-build of fatty acids that may have been lost or reduced in the myelin sheathing and elsewhere in the brain are replaced, to thereby decrease one""s susceptibility to MS or, in the case of initial symptoms, to prevent their re-occurrence.
It is in accordance with the present invention an object to re-introduce vital nutrients into the fatty tissue which surrounds and defines the myelin shield to, thereby, prevent and repair damage to the myelin sheath which may have occurred.